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  5. Label Information: Systane Ultra

FDA Label for Systane Ultra

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. USES
    3. WARNINGS
    4. DO NOT USE
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. OTHER
    13. KEEP OUT OF REACH OF CHILDREN.
    14. OTC - STOP USE
    15. OTC - KEEP OUT OF REACH OF CHILDREN
    16. PRINCIPAL DISPLAY PANEL

Systane Ultra Product Label

The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant
Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses



  • For the temporary relief of burning and irritation due to dryness of the eye
    • For the temporary relief of burning and irritation due to dryness of the eye
      • for the temporary relief of burning and irritation due to dryness of the eye
      • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings



For external use only                 

For external use only.

For external use only


Do Not Use



  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
      • if this product changes color or becomes cloudy
      • if you are sensitive to any ingredient in this product

When Using This Product



  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
      • do not touch tip of container to any surface to avoid contamination
      • replace cap after each use

Stop Use And Ask A Doctor If



you experience any of the following:

  • eye pain
  • changes in vision 
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • shake well before using 
  • put 1 or 2 drops in the affected eye(s) as needed
    • Shake well before using.
      • shake well before using
      • put 1 or 2 drops in the affected eye(s) as needed

Other Information



  • store at room temperature
    • Instill 1 or 2 drops in the affected eye(s) as needed.
    • Store at room temperature.
      • store at room temperature

Inactive Ingredients



aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD* (polyquarternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.


Questions?



In the U.S. call 1-800-757-9195
www.systane.com
[email protected]

In the U.S. call 1-800-757-9195
www.systane.com
[email protected]

In the U.S.
call 1-800-757-9195
[email protected]
www.systane.com


Other



Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Otc - Stop Use



Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Principal Display Panel



Systane*
ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor
Recommended
Dry Eye Brand†

Alcon®
STERILE
3 mL (0.1 FL OZ)

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor Recommended Brand1

Alcon
STERILE
3mL (0.1 FL OZ)

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor Recommended Brand1

Alcon
STERILE 
10  mL (⅓ FL OZ)

Systane® 
LUBRICANT EYE DROPS

ULTRA
HIGH PERFORMING DRY EYE RELIEF

Fast-acting hydration and lasting relief

Moisture rich formula

#1 Doctor Recommended Brand1

Alcon

STERILE 

10  mL (1/3 FL OZ)


* Please review the disclaimer below.